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Completed

NCT Number: NCT03171363

Gaze Contingent Feedback for Anxiety Disorders in Children

The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 69978, Israel

About this study

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. Attentional threat bias and Attentional control will also be measured to explore potential mediators of ABMT's effect on anxiety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of GAD, SOP, or SAD.
  • Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
  • Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.

Exclusion criteria

To be excluded youth must:

  • meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
  • show high likelihood of hurting themselves or others.
  • have not been living with a primary caregiver who is legally able to give consent for the child's participation.
  • be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
  • be involved currently in another psycho-social treatment.
  • have a serious vision problem that is not corrected with prescription lenses.
  • have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

Treatment and study plan

Gaze-contingent feedback

Behavioral

Participants will receive gaze-contingent feedback according to their viewing patterns

Primary outcomes

  1. Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)

    Time frame: Post treatment (1 week after treatment completion)

    The PARS assesses global anxiety severity across different anxiety disorders in children

Secondary outcomes

  1. Change from baseline in anxiety related emotional disorders symptoms - Child/Parent (the SCARED 41-item)

    Time frame: Post treatment (1 week after treatment completion)

    The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Gaze-Contingent Music Reward Treatment for Anxiety Disorders in Children: A Case Series

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 31, 2017
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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